Description:
A Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same household [HH] are a cluster), to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.
Start Date: May 19, 2019
Eligibility:
An index case is defined as an adult (18 years and older) with pulmonary MDR-TB who has started MDR-TB treatment within the past 90 days
An HHC is defined as a person who currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who reports exposure within 90 days prior to the index case starting MDR-TB treatment.
Also, shared >4 hours of indoor airspace with the index case during any one-week period prior to the index case starting MDR-TB treatment.
Only HHCs of index cases who are at high risk of developing TB will be enrolled into the study:
Children 0 to < 5 years of age regardless of tuberculin skin test (TST)/interferon gamma release assay (IGRA), or HIV status
Adults, adolescents, and children ≥ 5 years of age who are TST-positive (≥ 5 mm) and/or IGRA-positive and whose HIV status is negative, indeterminate, or unknown and who are not non-HIV immunosuppressed
Adults, adolescents, and children ≥ 5 years of age who are HIV-infected or are non-HIV immunosuppressed (defined as receiving anti-tumor necrosis factor (TNF) treatment, or being solid organ or hematologic transplant recipients), regardless of TST/IGRA status
To Participate in the study kindly reach us via: